PER-065-13招募中未知
A PHASE 3 MULTI-CENTER, OPEN-LABEL STUDY TO EVALUATE PHARMACOKINETICS, EFFICACY AND SAFETY OF ABATACEPT ADMINISTERED SUBCUTANEOUSLY (SC) IN CHILDREN AND ADOLESCENTS WITH ACTIVE POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PJIA) AND INADEQUATE RESPONSE (IR) TO BIOLOGIC OR NON BIOLOGIC DISEASE MODIFYING ANTI-RHEUMATIC DRUGS (DMARDS)
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 6 至 17（—）
入选标准
- •pJIA subjects (male or female), ages 2-17 years with active disease who had an insufficient therapeutic response or intolerance to at least one biologic or non biologic DMARD for at least 3 months prior to screening. Subjects with TNFα inadequate response or other prior biologics will be restricted to 30% of the population. Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease with ≥ 2 active joints and ≥ 2 joints with limitation of motion.
排除标准
- •Subjects with other rheumatic diseases or major chronic inflammatory/immunologic diseases, active uveitis,
- •systemic JIA with active systemic features (within a period of 6 months prior to enrollment), persistent Oligoarthritis
- •JIA, or failed more than two TNFα antagonists or other biological DMARDS will be excluded.
研究者
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